Disposables R&D Engineer

Stefanini Group is hiring!Stefanini is looking for Disposables R&D Engineer for Plymouth, MN location (Hybrid Work)For quick Apply, please reach out to Ashish Gupta- / for W2 candidates only! **Workers can be remote/hybrid but must be local and able to come into the office at least three days a week** This section focuses on the main purpose of the job in one to four sentences.Leads design and development of product changes within sustaining engineering for disposable medical devices.Schedule, budget, and lead engineering projects with minimal guidance.Serve as the technical expert for design change programs. (e.g. new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).Lead the creation and maintenance of design history files.Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.3 - 5 years of related experience in Class II or Class III disposables medical product development.Design for Six Sigma (DFSS) training or certification preferred.Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.Ability to train and coach others from technical expertise.Strong interpersonal, communication, collaboration and influencing skills.Ability to read, write and comprehend English. Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives. Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers. About Stefanini Group:The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.

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